ISO 9001 - Quality Management Systems
NSAI are hosting information seminars on ISO 9001:2015 in June 2014; for further information please see ISO9001:2015 Roadshow
ISO 9001:2008 is the world’s foremost quality management standard, used by hundreds of thousands of organizations in over 170 countries around the globe.
It sets out the essential requirements for a practical and effective quality management system (QMS) which is, in essence, a system for minimizing risk and maximizing opportunity.
ISO 9001:2008 was published in November 2008, updating the earlier ISO 9001: 2000.
It is part of a series of quality management system standards, sometimes referred to as ISO 9000. These comprise:
- ISO 9000 – Fundamentals and Vocabulary, which introduces the basic principles underlying management systems and explains the terminology
- ISO 9001 – Requirements, which specifies the criteria for certification
- ISO 9004 – Guidelines for performance improvements goes beyond ISO 9001 by identifying how ISO 9001 can be used as a springboard for improving the efficiency and effectiveness of a quality management system.
This suite of standards is designed to help organizations analyse and improve each element in their operations, from the selection of suppliers through to sales and distribution.
Among the many benefits of ISO 9001, the Standard helps organizations to improve customer satisfaction levels, internal efficiency and employee involvement.
ISO 9001 sets out eight key principles of quality management:
- Customer focus
- Involvement of people
- Process approach
- System approach to management
- Continual improvement
- Factual approach to decision making
- Mutually beneficial supplier relationship.
These eight principles are not auditable, but are fundamental attributes of any quality management system.
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Who uses ISO 9001?
ISO 9001 is used by a diverse array of organizations, from giant multinational corporations to local community groups.
The Standard is the first port of call for almost all organizations, large or small, public or private, that have decided to strengthen, streamline or review their management procedures.
It can be used to focus on improving performance in a particular department, plant or site. However, it is generally most effective when implemented throughout an organization at every level.
The Compatible Standard
ISO 9001 is designed to be compatible and easily integrated with other management systems standards such as:
Key elements of ISO 9001
ISO 9001 is based on the PDCA cycle – Plan-Do-Check-Act - and its key elements are:
- Establishing the quality management system
- Documenting the system
- Implementing the system
- Reviewing the results
- Maintaining the system
Improving the system.
Establishing an effective QMS
After purchasing ISO 9001, the first step towards a practical QMS is to identify your processes.
This can best be achieved by initially focusing on two broad categories, management and operations, then working out which processes flow from these.
Thereafter, it will be necessary to:
- Set out the criteria (aligned with the quality policy) by which the success of each process can be measured
- Work out which processes are interrelated
- Develop a system to check the results.
Each process should have an ‘owner’ who is responsible for monitoring and reporting on its success against the selected criteria.
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Documenting your QMS
ISO 9001 requires four tiers of documentation:
- A Quality Policy Manual setting out the direction of the QMS, including definitions, scope, objectives and necessary human and material resources
- A Procedure Manual describing the implementation of the policies, including detail such as areas of responsibility, linkages and workflow
- Work Instructions defining how specific tasks are to be performed
- Records including minutes, audits, reviews, test results, specifications, invoices and costs (the Standard sets out a comprehensive list of required records).
Implementing your QMS
Before you can assess the effectiveness of any QMS, it must first be put into practice. Every organization is different and the exact procedures will vary, depending on the size, scope and nature of your activities.
It is important to systematically implement the details as agreed: forms, equipment, instructions, allocation of personnel, etc.
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Reviewing your QMS
At appropriate intervals, the results of the QMS should be reviewed.
When the system is first up and running, it will be necessary to conduct reviews at short intervals, so that teething problems can be rectified early. After the QMS has matured, the intervals between reviews can be lengthened.
A key milestone in evaluating the QMS is the management review, a meeting which assesses whether the QMS has succeeded in meeting:
- Strategic objectives
- Process success criteria
- ISO 9001 requirements.
Maintaining your QMS
Every business will confront obstacles and challenges.
Success or failure can hinge on identifying these at an early stage and dealing with them effectively. Records should be designed to allow for the early detection and prompt reporting of problems.
As part of maintaining a QMS, businesses should continually monitor customer satisfaction. On its own, a system of handling complaints won’t necessarily be enough to prevent customers transferring their business to a competitor. It is vital to eliminate, or at least reduce, the volume of customer complaints and raise positive customer perceptions.
Improving your QMS
Improvement involves pinpointing challenges, actual and potential, and fixing them.
Actual problems that have occurred – e.g. a late delivery – should be rectified by what ISO 9001 refers to as a ‘corrective action’.
A corrective action may involve an actual customer complaint, a difficulty with a supplier or a faulty product. All corrective actions must be recorded.
Potential problems that have been identified as a result of a near miss – e.g. almost failing to make a delivery – should be tackled by what ISO 9001 defines as a ‘preventive action’.
Preventive actions can be handled in a similar way as corrective actions, though small companies may prefer to handle preventive action as part of their management review.
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